Home NDC 52000-045 U ICE COLD
Product NDC 52000-045
11-digit product format 520000045
Labeler code 52000
Product ID 52000-045_0718e1be-e778-00f3-e063-6394a90a114e
Type HUMAN OTC DRUG
Nonproprietary name menthol
Dosage form OINTMENT
Route TOPICAL
Labeler UNIVERSAL DISTRIBUTION CENTER LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-01
Substance CAMPHOR, (-)-; MENTHOL
Active strength .5; 1 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base U ICE COLD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR, (-)- .5 g/100g MENTHOL 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213N3S8275 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2056456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52000-045-01 U ICE COLD 227 g in 1 TUBE OINTMENT 227 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52000-045 U ICE COLD (MENTHOL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231008_752ef0cd-f12a-3b9e-e053-2991aa0abeb1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52000-045-01 52000004501 227 g in 1 TUBE (52000-045-01) 227 g 2018-08-01 0000-00-00 No No Current